NIH ANNOUNCES DRAFT STATEMENT ON SHARING RESEARCH DATA
Release Date: March 1, 2002
NOTICE: NOT-OD-02-035 (See NOT-OD-03-032 for Update)
National Institutes of Health
Data sharing promotes many goals of the National Institutes of Health's
(NIH) research endeavor. It is particularly important for unique data
that cannot be readily replicated. Data sharing allows scientists to
expedite the translation of research results into knowledge, products,
and procedures to improve human health. THE NIH IS DEVELOPING A
STATEMENT ON DATA SHARING THAT EXPECTS AND SUPPORTS THE TIMELY RELEASE
AND SHARING OF FINAL RESEARCH DATA FROM NIH-SUPPORTED STUDIES FOR USE
BY OTHER RESEARCHERS. INVESTIGATORS SUBMITTING AN NIH APPLICATION WILL
BE REQUIRED TO INCLUDE A PLAN FOR DATA SHARING OR TO STATE WHY DATA
SHARING IS NOT POSSIBLE. This statement will apply to extramural
scientists seeking grants, cooperative agreements, and contracts as
well as intramural investigators.
Institutions and individuals are invited to comment on the draft
policy. Additional information is available online on the NIH web site
at: http://grants.nih.gov/grants/policy/data_sharing/index.htm
Comments must be received no later than June 1, 2002. They should be
sent to the Office of Extramural Research, 1 Center Drive, MSC 0152,
Building 1, Room 150, Bethesda, MD 20817 or by email to dder@nih.gov
Following consideration of public comments and appropriate revisions,
it is expected that the new policy will be announced on August 1, 2002
with a proposed effective date of January 1, 2003.
Background Information
There are many reasons to share data from NIH-supported studies.
Sharing data reinforces open scientific inquiry, encourages diversity
of analysis and opinion, promotes new research, makes possible the
testing of new or alternative hypotheses and methods of analysis,
supports studies on data collection methods and measurement,
facilitates the education of new researchers, enables the exploration
of topics not envisioned by the initial investigators, and permits the
creation of new data sets when data from multiple sources are combined.
By avoiding the duplication of expensive data collection activities,
the NIH is able to support more investigators than it could if similar
data had to be collected de novo by each applicant.
NIH-supported basic research, clinical studies, surveys, and other
types of research produce data that may be shared. However, NIH
recognizes that sharing data about human research subjects presents
special challenges. The rights and privacy of people who participate
in NIH-sponsored research must be protected at all times. Thus, data
intended for broader use should be free of identifiers that would
permit linkages to individual research participants and variables that
could lead to deductive disclosure of individual subjects. Similarly,
NIH recognizes the need to protect patentable and other proprietary
data and the restriction on data sharing that may be imposed by
agreements with third parties. It is not the intent of this statement
to discourage, impede, or prohibit the development of commercial
products from federally funded research.
There are many ways to share data. Sometimes data are included in
publications. Investigators may distribute data under their own
auspices. Some investigators have placed data sets in public archives
while others have put data on a web site, building in protections for
privacy through the software while allowing analysis of the data.
Restricted access data centers or data enclaves facilitate analyses of
data too sensitive to share through other means. All of these options
achieve the goals of data sharing.
However, the NIH also recognizes that in some particular instances
sharing data may not be feasible. For example, studies with very small
samples or those collecting particularly sensitive data should be
shared only if stringent safeguards exist to ensure confidentiality and
protect the identity of subjects.
The NIH will expect investigators supported by NIH funding to make
their research data available to the scientific community for
subsequent analyses. Consequently, the NIH will require that data
sharing be addressed in grant applications (e.g., in sections related
to significance, budget, and the end of the research plan) and in the
review of applications. Funds for sharing or archiving data may be
requested in the original grant application or as a supplement to an
existing grant. Investigators who incorporate data sharing in the
initial design of the study can more readily and economically establish
adequate procedures for protecting the identities of participants and
provide a useful data set with appropriate documentation. Applicants
whose research will produce data that are not amenable to sharing
should include in the application reasons for not making the data
available. NIH encourages investigators to consult with an NIH Program
Administrator prior to submitting an application to determine the
appropriateness of data sharing and a suitable mechanism to disseminate
the data.
This statement on data sharing is an extension of NIH policy regarding
sharing research resources, which expects that recipients of NIH
support will provide prompt and effective access to research tools.
(See NIH Grants Policy, Part II Subpart A, Availability of Research
Results: Publications, Intellectual Property Rights, and Sharing
Biomedical Research Resources
(http://grants.nih.gov/archive/grants/policy/nihgps_2001/nihgps_2001.pdf)
This statement is also an extension of the PHS policy relating to the
distribution of unique research resources produced with PHS funding
(see http://grants.nih.gov/grants/guide/notice-files/not96-184.html)
Principles and guidelines for sharing biomedical research resources can
be found in online NIH reports at
http://www.nih.gov/science/models/sharing.html
and http://www.nih.gov/news/researchtools/index.htm. Moreover, this
statement on data sharing is consistent with the policies of many
scientific journals publishing the findings of NIH-supported research.